Safety and Efficacy of Different Antiviral Regimens for Hepatitis C Virus Relapse

Hepatitis C Clinical Trial

Official title:

Safety and Efficacy of Directly Acting Antiviral Agents in Genotype 4 Hepatitis C Virus Relapse Among Egyptian Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04662138
• Other study ID #: 0304769
• Status: Recruiting
• Start date: August 24, 2020
• Est. completion date: May 28, 2022

Study information

• Verified date: August 2020
• Source: Alexandria University
• Contact: Ahmed Kamal
• Phone: 01279734654
• Email: Ahmed.Kamal[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary goal of hepatitis C virus (HCV) Direct Acting Antivirals (DAAs) is to achieve undetectable HCV RNA in the blood. A response that should be maintained for at least 12 weeks from completion of therapy. This is called sustained virological response (SVR) which corresponds to cure of HCV infection as risk of later relapse is very small. SVR is important to achieve improvement in liver necroinflammation and fibrosis and to decrease complications of cirrhosis.

Failing to achieve SVR after treatment requires another regimen for these experienced patients.

Real-world data are always needed to evaluate and improve our practices. Here investigators aim to assess tolerability and efficacy of different regimens used for management of genotype 4 HCV relapse.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 28, 2022
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients with HCV relapse after sofosbuvir plus either Non-structural protein 5 A (NS5A) or protease inhibitor.

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Antivirals
• Hepatitis
• Hepatitis A
• Hepatitis C
• Recurrence
• Relapse

Intervention

Drug:
• directly acting antivirals
Different regimens given for genotype 4 relapse: Sofosbuvir/velpatasvir/voxilaprevir ±ribavirin; sofosbuvir/velpatasvir ±ribavirin; ombitasvir/paritaprevir/ritonavir+ ribavirin

Locations

Country	Name	City	State
Egypt	Alexandria University.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response		12 weeks after completion of treatment